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A TRIAL OF INTENSIVE CHEMOTHERAPY AND AUTOLOGOUS STEM CELL RECONSTITUTION FOR PATIENTS BETWEEN SIX AND SIXTY YEARS OF AGE, WITH NON-PROGRESSIVE GLIOBLASTOMA MULTIFORME OR DIFFUSE INTRINSIC BRAINSTEM TUMORS, FOLLOWING INITIAL LOCAL-FIELD IRRADIATION

Trial Information

A TRIAL OF INTENSIVE CHEMOTHERAPY AND AUTOLOGOUS STEM CELL RECONSTITUTION FOR PATIENTS BETWEEN SIX AND SIXTY YEARS OF AGE, WITH NON-PROGRESSIVE GLIOBLASTOMA MULTIFORME OR DIFFUSE INTRINSIC BRAINSTEM TUMORS, FOLLOWING INITIAL LOCAL-FIELD IRRADIATION

OBJECTIVES: I. Estimate the overall survival, progression-free interval, and time to
progression or recurrence in patients with nondisseminated glioblastoma multiforme or
diffuse intrinsic brain stem tumors that are nonprogressive following surgery (if feasible)
and involved-field irradiation and treated with intensive chemotherapy followed by
autologous peripheral blood stem cell (PBSC) or autologous bone marrow (ABM) rescue. II.
Estimate the toxicity of myeloablative chemotherapy with thiotepa (TSPA) followed by
carboplatin (CBDCA) in these patients. III. Evaluate the pharmacokinetic interactions of
high-dose CBDCA, TSPA, and triethylenephosphoramide (a metabolite of TSPA) and any impact on
subsequent toxicity. IV. Evaluate the effectiveness of autologous stem cells in restoring
hematopoiesis following myeloablative therapy.

PATIENT CHARACTERISTICS: Age: 6 to under 60 Performance status: Karnofsky 70%-100% (over
age 16) Lansky 70%-100% (ages 6-16) Hematopoietic: Not specified Hepatic: Bilirubin less
than 2.0 mg/dL AST or ALT less than 5 times normal PT and aPTT normal (consult with
principal investigator if abnormal) Renal: Creatinine clearance at least 50 mL/min/1.73
sqm Cardiovascular: No evidence of myocardial infarction or ischemia on EKG Other: No
active infection at time of leukapheresis Able to tolerate anticoagulation

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